DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 6, 7 and 9 are objected to because of the following informalities:
Regarding claims 6 and 7, the limitation “the outer shell” lacks antecedent basis. This should be replaced with –an outer shell—or the claim should depend from claim 2.
Regarding claim 9, the limitation “the filter liner” lacks antecedent basis and should read –a filter liner--
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 17 and thus its dependents, 18-22 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The limitation “a first chamber comprises a first void space formed by a face of a user…” claims a portion of a living organism and is thus rejected under 101. The examiner suggests rewording the claim to avoid claiming a human. For example, “wherein, a first void space is formed by the face seal and the first filter when worn by a user”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 and its dependents 18-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "the facepiece" in line 11 of the claim. There is insufficient antecedent basis for this limitation in the claim. For examination purposes the examiner will assume “the facepiece” should read –the face seal--
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker et al (US 2015/0047642), hereinafter Tucker.
Regarding claim 1, Tucker teaches a respiratory protective device (Figs. 1-2, paragraph 3), comprising:
a first frame having a first body perimeter (Fig. 2: 50, support structure), the first body perimeter forming a first opening (See Fig. 2: 50 has a perimeter with an opening);
a second frame having a second body perimeter (fig. 2: 40, paragraph 18, framing member) the second body perimeter forming a second opening (See fig. 2), the second frame being removably attachable to the first frame; (paragraph 18, the framing member 40 is attachable/detachable to a support structure 50 is use)
a filter having a filter body (Fig. 2: 30) and a lip portion extending from the filter body (Fig. 2: edge of filter body 30); and
a face seal having a body (Fig. 2: 20), the body forming a third opening and including a flange extending around the face seal (See fig. 2: opening with flange), the face seal attaches to the first frame, (paragraph 19, shaped molded base 20 attaches to support structure 50) wherein the flange is shaped to fit within the opening of the first body perimeter. (Fig. 1, so is contained within the opening of 50, paragraph 19, the perimeter of the support structure 50 is generally similar to the perimeter of the shaped molded base 20)
Tucker does not state the filter is disposed between the first frame and the second frame wherein a surface of the first body perimeter and surface of the second perimeter engages a lip portion.
However, Galinas teaches a respiratory protective device (Abstract, Fig. 7) which has a first frame member (Fig. 7: 92) and a second frame member (Fig. 7: 24) wherein the filter 12) is disposed between the first frame member and the second frame member (fig. 7, paragraph 31) and wherein the first body perimeter and a surface of the second perimeter engages the lip portion. (paragraph 9, See Fig. 60) It would have been obvious to a person or ordinary skill in the art to have modified the respiratory protective device of Tucker so that the filter is disposed between the first and second frame member as taught by Galinas in order to provide an arranged met with a hinged cover so that the filter may be easily changed. (paragraph 31)
Regarding claim 5, Tucker in view of Galinas teaches the device of claim 1, and Tucker further teaches wherein the first frame and second frame each comprising a plurality of connectors spaced about the first and second body perimeter. (Paragraph 18, the framing member may be attached to the support structure through any appropriate locking mechanism such as latches, overhangs pivot surfaces, twist insertions and the like)
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tucker in view of Galinas, and further in view of Epstein (US Pat. No. 9,468,783), hereinafter Epstein.
Regarding claim 4, Tucker in view of Galinas teaches the device of claim 1, but do not teach further comprising:
a filter liner removably coupled to an aft interior portion of the filter.
However, Epstein teaches a particulate filter which has a filter liner removably coupled to an aft interior portion of a filter. (Col. 11: lines 16-44, adding a release liner or backing to the filter material)
It would have been obvious to a person of ordinary skill in the art to have provided a filter liner to the aft surface of the filter to give the filter more substance in order to make it easier to assemble. (col. 11: lines 40-45)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tucker in view of Galinas, and further in view of Ging et al (US 2010/0229869), hereinafter Ging.
Regarding claim 8, Tucker in view of Galinas teaches the device of claim 1, and but does not teach wherein the flange forms a recess extending around a perimeter of the face seal body, a portion of the first frame is configured to couple with the recess to hold the face seal body to the first frame.
However, Ging teaches a mask assembly with a frame wherein a flange forms a recess extending around a perimeter, a portion of a second piece is configured to couple with the recess to hold the two pieces together. (Fig. 5C, channel 26 to connect to cushion 40).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have substituted the attachment method of Tucker in view of Galinas with the groove around the perimeter since either method provides an attachable/detachable method of connecting the face seal with the frame.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tucker in view of Galinas, and further in view of Morelli et al (US Pat. No. 8,443,806), hereinafter Morelli.
Regarding claim 11, Tucker in view of Galinas teaches the device of claim 1, but does not teach further comprising:
a seal check apparatus comprising a conical flanged cover having an associated aperture the seal check apparatus configured to sealably and detachably mate with a facepiece.
However, Morelli teaches a face seal check device (Abstract, Fig. 2)) comprising a conical flanged cover having an associated aperture (Fig. 4: conical cover having aperture), the seal check apparatus configured to sealably and detachably mate with a facepiece. Col. 3: lines 13-22, preferably a snap-fit connection for ease of installation and removal of the sealing device. Preferably has an overall inwardly tapered conical shape defining an aperture that is aligned with the central longitudinal axis.)
It would have been obvious to a person or ordinary skill in the art prior to the filing date of the invention to have provided Tucker in view of Galinas with a face seal check device as taught by Morelli in order to provide a way to check the seal of the mask. (Col. 1: lines 13-15)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Moulton et al (US 2018/0008848), hereinafter Moulton in view of Schmoegner et al (US Pat. No. 4,770,169), hereinafter Schmoegner.
Regarding claim 12, Moulton teaches a kit for respiratory protective devices (Paragraph 63), the kit comprising:
at least one respiratory protective device (Paragraph 63) comprising:
a first frame having a first body perimeter, the first body perimeter forming a first opening (Figs. 2A- 3: mask body);
a second frame having a second body perimeter (Fig. 3A: 30b), the second body perimeter forming a second opening (Fig. 3A: see openings in 30a), the second frame being removably attachable to the first frame; (Paragraph 13, the front piece is removable for filter replacement)
one or more filters, each filter having a filter body and a lip portion extending from the filter body (paragraph 63, multiple filters, Fig. 3a: filter 22 which has an edge), the filter disposed between the first frame and the second frame, (See Fig. 3A which shows exploded view of mask) wherein a surface of the first perimeter and a surface of the second perimeter engages the lip portion; (Paragraph 23, a flexible filter element is sandwiched between the front gill element and the mask body and the raised elements on the support elements of the mask body and the support elements on the front grill element exert pressure on the flexible filter element)
Moulton does not teach multiple face seals, wherein each face seal has a body, the body forming a third opening and a flange extending around the face seal, the face seal removably attachable to the first frame wherein the flange is shaped to fit within the opening of the first body perimeter, and wherein at least two face seals have different body shapes to fit different facial morphologies, and the flange is the same size for each of the multiple face seals.
However Tucker teaches a mask which has a face seal wherein each face seal has a body, (Fig. 2: 20) the body forming a third opening (Fig. 2)and a flange extending around the face seal, (Fig. 2: 20 has an opening for the face and a flange around the opening) the face seal removably attachable to the first frame (paragraph 20) wherein the flange is shaped to fit within the opening of the first body perimeter, (Fig. 1) and the flange is the same size for each of the multiple face seals.
It would have been obvious to a person of ordinary skill in the art to have provided Moulton with the separate face seal of Tucker since the courts have held that making parts separable is merely a matter of design choice. In this case it would be obvious to make the parts separable to enable better cleaning of the device.
Moulton in view of Tucker does not teach multiple face seals wherein at least two face seals have different body shapes to fit different facial morphologies.
However, Schmoegner teaches a mask (Abstract) with multiple face seals with different body shapes to fit different facial morphologies. (Col. 5: lines 50-60, select from a variety of types, shapes, sizes)
It would have been obvious to a person of ordinary skill in the art to have included multiple seals in the kit of Moulton so that an appropriate seal for a particular user can be chosen. (Col 5: lines 56-59)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Moulton et al (US 2018/0008848), hereinafter Moulton in view of Schmoegner et al (US Pat. No. 4,770,169), hereinafter Schmoegner, and further in view of and further in view of Epstein (US Pat. No. 9,468,783), hereinafter Epstein.
Regarding claim 13, Moulton in view of Tucker and Schmoegner teaches the kit of claim 12, and Moulton further teaches comprising:
one or more filter liners, the filter liner configured to be removably coupled to an aft interior portion of the one or more filters.
However, Epstein teaches a particulate filter which has a filter liner removably coupled to an aft interior portion of a filter. (Col. 11: lines 16-44, adding a release liner or backing to the filter material)
It would have been obvious to a person of ordinary skill in the art to have provided a filter liner to the aft surface of the filter to give the filter more substance in order to make it easier to assemble. (col. 11: lines 40-45)
Allowable Subject Matter
Claims 2-3, 6-7, 9-10, 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 2, It would not be obvious to modify the mask of Tucker in view of Galinas to include an outer shell having a body with a recessed portion extending along an upper portion of a rear side of the outer shell; and
an outer shell covering attached to a front side of the outer shell.
Regarding claim 9, It would not be obvious to modify Tucker, Galinas and Epstein so that wherein the filter liner has a body perimeter that couples with a portion of the first frame and the flange of the face seal.
Regarding claim 14, it would not be obvious to modify the kit of claim 12 to include
one or more shells, each shell having a body with a recesses portion extending along an upper portion of a rear side of the shell without the benefit of impermissible hindsight.
Claims 17—22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and U.S.C. 101 as set forth in this Office action.
Regarding claim 17, The prior art teaches a respiratory device comprising a face seal, a filter, an outer shell, a first chamber comprising a first void space but does not teach a second chamber comprising a second void space formed between the first filter and the outer shell, a frame positioned between said first chamber and said second chamber wherein the frame joins the face seal to the outer shell, a sealing ring positioned between the frame and the outer shell respiratory protective device, comprising:
a face seal;
a first filter;
an outer shell;
a first chamber, wherein the first chamber comprises a first void space formed by a face of a user, the face seal and the first filter, wherein the first void space extends from the face of the user to the first filter;
a second chamber, wherein the second chamber comprises a second void space formed between the first filter and the outer shell;, wherein the sealing ring holds the first filter in contact with the frame, forming a seal; and a filter liner, removably attached to the first filter on a surface facing the first chamber wherein the filter liner is removable while retaining a seal separating the first seal chamber and the second chamber.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:00 pm MT.
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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
